The goal of this clinical study is to learn more about the study drug, Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), safety, tolerability, and pharmacokinetics (how B/F/TAF is absorbed, modified, distributed, and removed from the body of the participants) in neonates exposed to human immunodeficiency virus type 1 (HIV-1).
The primary objective of this study is to evaluate the safety and plasma pharmacokinetics (PK) (how B/F/TAF is absorbed, modified, distributed, and removed from the body of the participants) of B/F/TAF tablet for oral suspension (TOS) in full-term neonates exposed to HIV-1 but uninfected.
Eligibility
Sex
ALL
Min age
—
Max age
120 Hours
Healthy volunteers
No
Key Inclusion Criteria:
Mother inclusion criteria:
* Be on standard of care (SOC) antiretroviral therapy for human immunodeficiency virus type 1 (HIV-1) treatment.
* Have confirmed HIV-1 infection based on positive test results obtained from medical records.
Neonate inclusion criteria:
* Be born at term (≥ 37.0 weeks gestational age).
* Be able to take oral medication.
* Be ≤ 120 hours of life at enrollment.
* Have a birth weight ≥ 2.5 kg.
* Is receiving or plans to receive HIV-1 SOC prophylaxis regimen with 1 antiretroviral (ARV) to prevent perinatal transmission.
Key Exclusion Criteria:
Mother exclusion criteria:
* Has a maternal-fetal blood group incompatibility identified by clinically relevant antibody that can cause hemolytic diseases of the neonate.
* Is breastfeeding or plans to breastfeed while on bictegravir (BIC) or emtricitabine (FTC) containing regimen. Mothers on BIC or FTC containing regimen, but not breastfeeding, can be enrolled in the study.
Neonate exclusion criteria:
* Had prior or expected to require blood exchange transfusion.
* Is receiving or plans to receive any component of B/F/TAF or dolutegravir as part of their SOC ARV prophylaxis regimen.
* Has a documented positive HIV-1 nucleic acid test.
* Has Grade 2 or higher aspartate aminotransferase, total bilirubin, hemoglobin, platelets or creatinine. Has Grade 1 or higher alanine aminotransferase.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary outcome measure(s)
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAs) Though Week 8 After Neonate Birth — First dose date up to 8 Weeks
Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 8 After Neonate Birth — First dose date up to 8 Weeks
Pharmacokinetic (PK) parameters for Bictegravir (BIC): AUCinf — Predose up to 72 hours postdose AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time.
PK parameters for BIC: AUClast — Predose up to 72 hours postdose AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.
PK parameters for BIC: AUC0-24h — Predose up to 24 hours postdose AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours.
PK parameters for BIC: Cmax — Predose up to 72 hours postdose Cmax is defined as the maximum observed concentration of drug.
PK parameters for BIC: Tmax — Predose up to 72 hours postdose Tmax is defined as the time (observed time point) of Cmax.
PK parameters for BIC: Cmin — Predose up to 72 hours postdose Cmin is defined as the minimum observed concentration of drug.
PK parameters for BIC: C24h — At 24 hours postdose C24h is defined as the concentration of drug at time 24 hours.
PK parameters for BIC: t1/2 — Predose up to 72 hours postdose t1/2 is defined as the terminal elimination half-life.
PK parameters for BIC: Apparent CL/F — Predose up to 72 hours postdose Apparent CL/F is defined as the apparent total body clearance for extravascular administration.
PK parameters for BIC: Apparent Vz/F — Predose up to 72 hours postdose Apparent Vz/F is defined as the apparent volume of distribution based on the terminal phase.
Trial sites (7)
Facility
City
Region
Status
Ronald Reagan UCLA Medical Center (inpatient hospital)
Los Angeles
California
Grady Health System - Ponce de Leon Center
Atlanta
Georgia
St Jude Children's Research Hospital
Memphis
Tennessee
Family Centre for Research with Ubuntu (FAMCRU)
Cape Town
South Africa
Durban International Clinical Research Site, Enhancing Care Foundation
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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